{"analyses":[{"ciLowerLimit":"0.73","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.13","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Placebo vs. Trastuzumab + Taxane","groupDescription":"Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \\[trastuzumab and/or lapatinib\\], yes \\[no trastuzumab and/or lapatinib\\]), and visceral disease (present, absent).","groupIds":["OG000","OG001"],"nonInferiorityComment":"The study was powered for superiority with target hazard ratio (HR) equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was less than (\\<) 1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \\<1.00.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","pValue":"0.3125","pValueComment":"Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.","paramType":"Hazard Ratio (HR)","paramValue":"0.91","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.69","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.08","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab + Taxane","groupDescription":"Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \\[trastuzumab and/or lapatinib\\], yes \\[no trastuzumab and/or lapatinib\\]), and visceral disease (present, absent).","groupIds":["OG000","OG002"],"nonInferiorityComment":"The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm. Non-inferiority was established if the upper bound of the 97.5% CI was \\<1.1765. Superiority was achieved if the upper bound of the 97.5% CI was \\<1.00.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","pValue":"0.1407","pValueComment":"Test and p-value apply for superiority test. Two-sided significance level of 2.5% was used to adjust for independent comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.","paramType":"Hazard Ratio (HR)","paramValue":"0.87","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.73","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.13","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs. Trastuzumab Emtansine + Placebo","groupDescription":"Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \\[trastuzumab and/or lapatinib\\], yes \\[no trastuzumab and/or lapatinib\\]), and visceral disease (present, absent).","groupIds":["OG001","OG002"],"nonInferiorityComment":"The study was powered for superiority with target HR equal to 0.75, as well as for non-inferiority with HR equal to 1.1765 for comparison between each of the trastuzumab emtansine-containing arms and the trastuzumab + taxane arm.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","pValue":"0.3075","pValueComment":"Test and p-value apply for superiority test. Primary endpoint did not meet superiority of PFS for trastuzumab emtansine + pertuzumab versus trastuzumab + taxane (two-sided significance level 2.5%); thus, tests and p-value are considered descriptive.","paramType":"Hazard Ratio (HR)","paramValue":"0.91","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.4","upperLimit":"14.9","value":"13.7"},{"groupId":"OG001","lowerLimit":"10.9","upperLimit":"16.8","value":"14.1"},{"groupId":"OG002","lowerLimit":"12.5","upperLimit":"18.8","value":"15.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"365"},{"groupId":"OG001","value":"367"},{"groupId":"OG002","value":"363"}],"units":"Participants"}],"description":"Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.","id":"OG000","title":"Trastuzumab + Taxane"},{"description":"Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.","id":"OG001","title":"Trastuzumab Emtansine + Placebo"},{"description":"Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.","id":"OG002","title":"Trastuzumab Emtansine + Pertuzumab"}],"paramType":"MEDIAN","populationDescription":"ITT Population.","reportingStatus":"POSTED","timeFrame":"Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)","title":"Progression-Free Survival (PFS) According to IRF Assessment","type":"PRIMARY","unitOfMeasure":"months"}